Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT00025818
Status:
COMPLETED
Last Update Posted:
2011-05-30
First Post:
2001-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007638', 'term': 'Keratoconjunctivitis Sicca'}, {'id': 'D012859', 'term': "Sjogren's Syndrome"}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D045743', 'term': 'Scleroderma, Diffuse'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D007637', 'term': 'Keratoconjunctivitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-27', 'studyFirstSubmitDate': '2001-10-26', 'studyFirstSubmitQcDate': '2001-10-26', 'lastUpdatePostDateStruct': {'date': '2011-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['dry eyes', 'rheumatoid arthritis', 'Lupus', "Sjogren's syndrome", 'myositis', 'scleroderma', 'autoimmune disorder'], 'conditions': ['Keratoconjunctivitis Sicca', "Sjogren's Syndrome", 'Lupus Erythematosus, Systemic', 'Arthritis, Rheumatoid', 'Scleroderma, Systemic']}, 'descriptionModule': {'briefSummary': 'A six-month clinical research trial to evaluate the effectiveness of an investigational medication for the treatment of dry eye syndrome in patients that have been diagnosed with moderate to severe dry eye syndrome, an autoimmune disorder AND/OR females 65 years of age or older.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Eighteen years or older\n* Diagnosis of moderate to severe dry eyes for at least 6 months and meet one or all of the following criteria:\n* Diagnosis of autoimmune disorder\n* Female 65 years of age or older'}, 'identificationModule': {'nctId': 'NCT00025818', 'briefTitle': 'Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '192371-011-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ophthalmic Emulsion', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Eyecare of La Jolla', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Opticare', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '33629', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Brandon Eye Clinic', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'UIC Eye Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Hunkleler Eye Center', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '01453', 'city': 'Leominster', 'state': 'Massachusetts', 'country': 'United States', 'facility': "D'Ambrosio Eye Care", 'geoPoint': {'lat': 42.52509, 'lon': -71.75979}}, {'zip': '48604', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Great Lakes Eye Institute', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '12159', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Cornea Consultants of Albany', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11201', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': "Dr. Freedman's Office", 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11790', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': "Dr. Wittpen's Office", 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cole Eye Institute', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97223', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Northwest Cornea', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '79903', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Corona Research', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Therapeutic Area Head', 'oldOrganization': 'Allergan, Inc'}}}}